Fit For Function: A Community Wellness Program for Persons With Stroke
25. juni 2019 oppdatert av: McMaster University
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System.
Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke.
The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively.
The hospital within each region will provide specialized on-site physiotherapy consultative support.
The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.
Studietype
Intervensjonell
Registrering (Faktiske)
218
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Brantford, Ontario, Canada
- The Brantford Family YMCA
-
Hamilton, Ontario, Canada, L8P 2Z1
- Downtown Hamilton YMCA
-
St. Catharines, Ontario, Canada, L2N 7P9
- The Walker Family YMCA
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- diagnosed with stroke
- 18 years of age or older
- community dwelling
- able to walk 10m independently, with or without an assistive device
- medically approved by a physician to participate
- able to tolerate 60 minutes of activity with rest intervals
- able to independently follow instructions
Exclusion Criteria:
- involved in an active rehabilitation program
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fit For Function Program
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors.
|
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors
|
|
Aktiv komparator: Standard YMCA membership
A 12 week standard YMCA membership.
|
A 12 week standard YMCA membership.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Reintegration to Normal Living Index (RNL) from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
|
baseline, 12 weeks, 24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
|
baseline, 12 weeks, 24 weeks
|
|
Change in The Short Portable Performance Tests (SPPT) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
|
baseline, 12 weeks, 24 weeks
|
|
Change in The Six Minute Walk Test (6MWT) from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
|
baseline, 12 weeks, 24 weeks
|
|
Change in Strength: Grip and Knee extension from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
Hand-held dynamometry will measure the average strength of three trials.
|
baseline, 12 weeks, 24 weeks
|
|
Change in The EQ-5D score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This is a generic utility-based health related quality of life questionnaire.
|
baseline, 12 weeks, 24 weeks
|
|
Change in The Patient Activation Measure (PAM) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
|
baseline, 12 weeks, 24 weeks
|
|
Change in The Body Mass Index (BMI) score from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
|
baseline, 12 weeks, 24 weeks
|
|
Change in Blood lipid levels from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
|
baseline, 12 weeks, 24 weeks
|
|
Change in blood glucose levels from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
|
baseline, 12 weeks, 24 weeks
|
|
Change in blood inflammatory markers from baseline
Tidsramme: baseline, 12 weeks, 24 weeks
|
12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
|
baseline, 12 weeks, 24 weeks
|
|
Healthcare Utilization Questionnaire
Tidsramme: 0- 24 weeks
|
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
|
0- 24 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Julie Richardson, PhD, McMaster University
- Hovedetterforsker: Ada Tang, PhD, McMaster University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2014
Primær fullføring (Faktiske)
1. november 2018
Studiet fullført (Faktiske)
1. november 2018
Datoer for studieregistrering
Først innsendt
14. oktober 2014
Først innsendt som oppfylte QC-kriteriene
3. mars 2016
Først lagt ut (Anslag)
9. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FFF133486
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System.
Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .